Leg Lymphoedema, Lower Extremity Lymphoedema
Conditions
Keywords
lymphedema, lymphoedema, leg lymphoedema, lower extremity lymphoedema, pneumatic compression device
Brief summary
Proof of principle study in order to determine if there is a difference in treatment effect across the 3 study groups when treating lower extremity lymphoedema using a pneumatic compression device.
Detailed description
This is a single center, 3 arm, prospective, randomized, clinical trial to assess the difference between 3 treatment options for achieving a measurable physiologic effect on lower extremity lymphedema with pneumatic compression device. Each intervention arm will include 10 completed subjects for a total of 30 completed subjects.
Interventions
DEVICEpneumatic compression - 1 hour per day
Pneumatic compression treatment once per day (1 hour)
DEVICEpneumatic compression - 2 hours per day
pneumatic compression treatment twice per day in the AM & PM (2 hours)
DEVICEpneumatic compression - 4 hours per day
pneumatic compression treatment twice per day consisting of 2 consecutive 1 hour treatments in the AM & PM (4 hours)
Sponsors
Tactile Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must be ≥ 18 years old * Subjects must have a diagnosis of primary or secondary Stage 2 unilateral or bilateral lower extremity lymphoedema * Must currently be using adequate compression garment(s) as determined by the clinician: (Garments must be at least 20mmHg and no more than 3 months old and must be worn upon rising and removed at bedtime) * Subjects must have clinically relevant excess limb swelling as determined by clinician pitting test * Must be able to attend all required in-clinic treatment visits
Exclusion criteria
* Diagnosis of active or recurrent cancer, or less than 3 months at the time of initial evaluation from the completion of chemotherapy, radiation therapy, or primary surgery for the treatment of cancer * Active infection or inflammation * Active thrombophlebitis (within the last 2 months) * History of pulmonary embolism (within the last 2 months) * Documented history of deep chronic venous insufficiency or deep venous obstruction with a reflux duration of \> 2 second in the deep system or any history of deep vein thrombosis (DVT) * History of pulmonary edema * History of congestive heart failure * History of chronic kidney disease with a glomerular filtration rate (GFR) of less than 30 mls per minute * Poorly controlled asthma * Symptomatic or severe peripheral artery disease (defined by current lifestyle-limiting claudication or critical limb ischemia) * Presence of an open wound or ulcer of any etiology * Diagnosis of lipoedema and lipolymphoedema * Currently using an in-home pneumatic compression device * Metal implant(s) that would interfere with bioimpedance equipment * Pacemaker or other implanted electronic device(s) * Unable or unwilling to remove bandaging from treatment regimen while participating in the study * Pregnant * Any condition where increased venous and lymphatic return is undesirable * Unable or unwilling to participate in all aspects of the study protocol and/or unable to provide informed consent * Currently participating in another clinical trial * Currently using diuretics * BMI \> 40
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcomes - MYMOP | Change baseline to final day (day 12 for Group A and day 5 for Groups B and C) | Changes in patient-determined symptoms\* and change in affect the symptoms had on the subject. Measured via MYMOP (Measure Yourself Medical Outcome Profile) questionnaire. A low score indicates a good outcome. Scores range from 0 (as good as can be) to 6 (as bad as can be). \*Recorded symptoms were: Gr A, 1st symptom: none, abdominal pain and discomfort, swelling, physical, and worrying about granddaughters Gr B, 1st symptom: arthritis, hayfever, look of fat foot, right hand area of neck and shoulder, stairs, and swelling Gr C, 1st symptom: none, energy during dancing and gardening, frustration of not going out on own, swelling, mild longstanding depression, and MPT joint at base of small toe Gr A, 2nd symptom: fatigue, heaviness of leg, mental, and pain under knee Gr B, 2nd symptom: narrowed choice of footwear, shower in bath, and swollen left foot Gr C, 2nd symptom: being tired and aching all over, and shoes and clothing |
| Change in Skin Tone | Change baseline to final day (day 12 for Group A and day 5 for Groups B and C) | Change in skin tone (fibrosis) measured via tonometry. The tonometer is a mechanical device that gives an indication of the resistance of tissue to compression. It is used in lymphedema to give an estimate of the extent of pitting and fibrotic induration. Tonometry measures were collected at 5 anatomical locations. A negative value is associated with a clinically desirable decrease in tone. |
| Limb Volume (ml) | Change baseline to final day (day 12 for Group A and day 5 for Groups B and C) | Limb volume changes measured via perometry reported in change of ml of fluid. A negative value is associated with the clinically-desirable decrease in fluid. |
| Limb Volume (% Change) | Change baseline to final day (day 12 for Group A and day 5 for Groups B and C) | Limb volume changes measured via perometry reported in percent reduction. A negative value is associated with the clinically-desirable decrease in fluid. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Activity Level | Day 1 compared to final treatment day (day 12 for Group A and day 5 for Groups B and C) | Change in number of steps as accumulated each day monitored through use of a pedometer. A positive number indicates an increase in step count (activity) while a negative number indicates a decrease in step count. |
| Cellular Fluid Changes (Ohms) | Change after initial treatment on day 1 and change baseline to end of day 5 for all groups | Changes in extra cellular fluid (ECF) on treated leg measured by bioimpedance. A negative number is indicative of a clinically desirable reduction in ECF. |
| Cellular Fluid Changes (% Change) | Change after initial treatment on day 1 and change baseline to end of day 5 for all groups | Changes in extra cellular fluid (ECF) on treated leg measured by bioimpedance. A negative number is indicative of a clinically desirable reduction in ECF. |
| Incidence of Complications | Change baseline to final day (day 12 for Group A and day 5 for Groups B and C) | Number of complications experienced. Incidence based on clinician assessment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Skin Thickness | Change baseline to final day (day 12 for Group A and day 5 for Groups B and C) | Change in skin thickness measured by ultrasound. Ultrasound measures were collected at 5 anatomical locations. A negative value is associated with a clinically desirable reduction in skin thickness (a surrogate measure of oedema). |
| Change in Local Tissue Water (LTW) | Change baseline to final day (day 12 for Group A and day 5 for Groups B and C) | Change in local tissue water (LTW) within the skin measured by MoistureMeterD (MMD). MMD measures were collected at 5 anatomical locations using 2 probes: medium (M25) and large (L50). A negative value is associated with a clinically desirable decrease in LTW (a surrogate measure of oedema). |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A 12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily) | 7 |
| Group B 5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily) | 7 |
| Group C 5 consecutive days undergoing 2 consecutive 1-hour pneumatic compression treatments in the AM and again in the PM (4 hours total daily) | 7 |
| Total | 21 |
Baseline characteristics
| Characteristic | Group A | Total | Group C | Group B |
|---|---|---|---|---|
| Age, Continuous | 65.5 years STANDARD_DEVIATION 6.7 | 58.0 years STANDARD_DEVIATION 13.8 | 50.4 years STANDARD_DEVIATION 18.3 | 58.1 years STANDARD_DEVIATION 11.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 20 Participants | 6 Participants | 7 Participants |
| Region of Enrollment United Kingdom | 7 participants | 21 participants | 7 participants | 7 participants |
| Sex: Female, Male Female | 5 Participants | 18 Participants | 6 Participants | 7 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 0 / 7 | 0 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 | 0 / 7 |
Outcome results
Primary
Change in Skin Tone
Change in skin tone (fibrosis) measured via tonometry. The tonometer is a mechanical device that gives an indication of the resistance of tissue to compression. It is used in lymphedema to give an estimate of the extent of pitting and fibrotic induration. Tonometry measures were collected at 5 anatomical locations. A negative value is associated with a clinically desirable decrease in tone.
Time frame: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Change in Skin Tone | Abdominal Wall (7 cm below umbilicus) | 0.3 mm | Standard Deviation 0.5 |
| Group A | Change in Skin Tone | 7 cm From Bottom of Patella (along midline) | -0.6 mm | Standard Deviation 1.5 |
| Group A | Change in Skin Tone | 7 cm Below Inguinal Crease (along midline) | -0.2 mm | Standard Deviation 5 |
| Group A | Change in Skin Tone | Dorsum of Central Foot | 0.1 mm | Standard Deviation 0.7 |
| Group A | Change in Skin Tone | 7 cm From Top of Patella (along midline) | -0.3 mm | Standard Deviation 1.2 |
| Group A | Change in Skin Tone | Posterior to Medial Malleolus | -0.3 mm | Standard Deviation 1.6 |
| Group B | Change in Skin Tone | 7 cm From Top of Patella (along midline) | -0.7 mm | Standard Deviation 3.6 |
| Group B | Change in Skin Tone | 7 cm Below Inguinal Crease (along midline) | -0.9 mm | Standard Deviation 3 |
| Group B | Change in Skin Tone | Posterior to Medial Malleolus | -0.7 mm | Standard Deviation 3.6 |
| Group B | Change in Skin Tone | Abdominal Wall (7 cm below umbilicus) | -0.7 mm | Standard Deviation 2.4 |
| Group B | Change in Skin Tone | Dorsum of Central Foot | 0.5 mm | Standard Deviation 2 |
| Group B | Change in Skin Tone | 7 cm From Bottom of Patella (along midline) | 0.2 mm | Standard Deviation 2 |
| Group C | Change in Skin Tone | Abdominal Wall (7 cm below umbilicus) | 0.3 mm | Standard Deviation 0.5 |
| Group C | Change in Skin Tone | Dorsum of Central Foot | 0.2 mm | Standard Deviation 1.1 |
| Group C | Change in Skin Tone | Posterior to Medial Malleolus | -1.2 mm | Standard Deviation 3.3 |
| Group C | Change in Skin Tone | 7 cm From Bottom of Patella (along midline) | 0.8 mm | Standard Deviation 1.1 |
| Group C | Change in Skin Tone | 7 cm From Top of Patella (along midline) | -0.1 mm | Standard Deviation 1.1 |
| Group C | Change in Skin Tone | 7 cm Below Inguinal Crease (along midline) | -0.8 mm | Standard Deviation 2.1 |
Primary
Limb Volume (% Change)
Limb volume changes measured via perometry reported in percent reduction. A negative value is associated with the clinically-desirable decrease in fluid.
Time frame: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Limb Volume (% Change) | -2.6 % reduction | Standard Deviation 1.1 |
| Group B | Limb Volume (% Change) | -0.7 % reduction | Standard Deviation 1.3 |
| Group C | Limb Volume (% Change) | 0.6 % reduction | Standard Deviation 4.5 |
Primary
Limb Volume (ml)
Limb volume changes measured via perometry reported in change of ml of fluid. A negative value is associated with the clinically-desirable decrease in fluid.
Time frame: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Limb Volume (ml) | -197 ml | Standard Deviation 78 |
| Group B | Limb Volume (ml) | -60 ml | Standard Deviation 126 |
| Group C | Limb Volume (ml) | 45 ml | Standard Deviation 381 |
Primary
Patient Reported Outcomes - MYMOP
Changes in patient-determined symptoms\* and change in affect the symptoms had on the subject. Measured via MYMOP (Measure Yourself Medical Outcome Profile) questionnaire. A low score indicates a good outcome. Scores range from 0 (as good as can be) to 6 (as bad as can be). \*Recorded symptoms were: Gr A, 1st symptom: none, abdominal pain and discomfort, swelling, physical, and worrying about granddaughters Gr B, 1st symptom: arthritis, hayfever, look of fat foot, right hand area of neck and shoulder, stairs, and swelling Gr C, 1st symptom: none, energy during dancing and gardening, frustration of not going out on own, swelling, mild longstanding depression, and MPT joint at base of small toe Gr A, 2nd symptom: fatigue, heaviness of leg, mental, and pain under knee Gr B, 2nd symptom: narrowed choice of footwear, shower in bath, and swollen left foot Gr C, 2nd symptom: being tired and aching all over, and shoes and clothing
Time frame: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Patient Reported Outcomes - MYMOP | First Symptom (see Outcome Measure Description) | -1.8 score on a scale | Standard Deviation 1.9 |
| Group A | Patient Reported Outcomes - MYMOP | Second Symptom (see Outcome Measure Description) | -1.3 score on a scale | Standard Deviation 1.2 |
| Group A | Patient Reported Outcomes - MYMOP | Activity | -1.4 score on a scale | Standard Deviation 0.9 |
| Group A | Patient Reported Outcomes - MYMOP | Well-Being | -0.8 score on a scale | Standard Deviation 1.3 |
| Group B | Patient Reported Outcomes - MYMOP | Well-Being | -0.3 score on a scale | Standard Deviation 1.8 |
| Group B | Patient Reported Outcomes - MYMOP | First Symptom (see Outcome Measure Description) | -0.7 score on a scale | Standard Deviation 0.8 |
| Group B | Patient Reported Outcomes - MYMOP | Activity | -1.0 score on a scale | Standard Deviation 1.7 |
| Group B | Patient Reported Outcomes - MYMOP | Second Symptom (see Outcome Measure Description) | 0 score on a scale | Standard Deviation 0 |
| Group C | Patient Reported Outcomes - MYMOP | Well-Being | 0 score on a scale | Standard Deviation 0 |
| Group C | Patient Reported Outcomes - MYMOP | Second Symptom (see Outcome Measure Description) | -1.5 score on a scale | Standard Deviation 0.7 |
| Group C | Patient Reported Outcomes - MYMOP | Activity | -0.5 score on a scale | Standard Deviation 0.7 |
| Group C | Patient Reported Outcomes - MYMOP | First Symptom (see Outcome Measure Description) | -0.3 score on a scale | Standard Deviation 1.3 |
Secondary
Activity Level
Change in number of steps as accumulated each day monitored through use of a pedometer. A positive number indicates an increase in step count (activity) while a negative number indicates a decrease in step count.
Time frame: Day 1 compared to final treatment day (day 12 for Group A and day 5 for Groups B and C)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Activity Level | 28 steps | Standard Deviation 281 |
| Group B | Activity Level | -1284 steps | Standard Deviation 2144 |
| Group C | Activity Level | 1240 steps | Standard Deviation 1916 |
Secondary
Cellular Fluid Changes (% Change)
Changes in extra cellular fluid (ECF) on treated leg measured by bioimpedance. A negative number is indicative of a clinically desirable reduction in ECF.
Time frame: Change after initial treatment on day 1 and change baseline to end of day 5 for all groups
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Cellular Fluid Changes (% Change) | ECF change following initial treatment (percent) | -2.5 percent fluid change | Standard Deviation 6.9 |
| Group A | Cellular Fluid Changes (% Change) | ECF change from baseline to end of day 5 (percent) | -4.9 percent fluid change | Standard Deviation 8 |
| Group B | Cellular Fluid Changes (% Change) | ECF change following initial treatment (percent) | -4.5 percent fluid change | Standard Deviation 6.4 |
| Group B | Cellular Fluid Changes (% Change) | ECF change from baseline to end of day 5 (percent) | -2.0 percent fluid change | Standard Deviation 10.5 |
| Group C | Cellular Fluid Changes (% Change) | ECF change following initial treatment (percent) | -1.2 percent fluid change | Standard Deviation 6.6 |
| Group C | Cellular Fluid Changes (% Change) | ECF change from baseline to end of day 5 (percent) | 1.1 percent fluid change | Standard Deviation 11.9 |
Secondary
Cellular Fluid Changes (Ohms)
Changes in extra cellular fluid (ECF) on treated leg measured by bioimpedance. A negative number is indicative of a clinically desirable reduction in ECF.
Time frame: Change after initial treatment on day 1 and change baseline to end of day 5 for all groups
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Cellular Fluid Changes (Ohms) | ECF change following initial treatment (ohms) | -5.8 ohms | Standard Deviation 17.4 |
| Group A | Cellular Fluid Changes (Ohms) | ECF change from baseline to end of day 5 (ohms) | -12.3 ohms | Standard Deviation 22 |
| Group B | Cellular Fluid Changes (Ohms) | ECF change following initial treatment (ohms) | -12.1 ohms | Standard Deviation 19 |
| Group B | Cellular Fluid Changes (Ohms) | ECF change from baseline to end of day 5 (ohms) | -4.6 ohms | Standard Deviation 27.2 |
| Group C | Cellular Fluid Changes (Ohms) | ECF change following initial treatment (ohms) | -3.8 ohms | Standard Deviation 15.1 |
| Group C | Cellular Fluid Changes (Ohms) | ECF change from baseline to end of day 5 (ohms) | 2.1 ohms | Standard Deviation 24.5 |
Secondary
Incidence of Complications
Number of complications experienced. Incidence based on clinician assessment.
Time frame: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A | Incidence of Complications | 0 Complications |
| Group B | Incidence of Complications | 0 Complications |
| Group C | Incidence of Complications | 0 Complications |
Other Pre-specified
Change in Local Tissue Water (LTW)
Change in local tissue water (LTW) within the skin measured by MoistureMeterD (MMD). MMD measures were collected at 5 anatomical locations using 2 probes: medium (M25) and large (L50). A negative value is associated with a clinically desirable decrease in LTW (a surrogate measure of oedema).
Time frame: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Change in Local Tissue Water (LTW) | M25 Probe: Dorsum of Central Foot | 1.9 cm | Standard Deviation 5.8 |
| Group A | Change in Local Tissue Water (LTW) | L50 Probe: Dorsum of Central Foot | 6.4 cm | Standard Deviation 10.6 |
| Group A | Change in Local Tissue Water (LTW) | M25 Probe: Posterior to Medial Malleolus | 2.5 cm | Standard Deviation 6 |
| Group A | Change in Local Tissue Water (LTW) | L50 Probe: Posterior to Medial Malleolus | -2.3 cm | Standard Deviation 5.4 |
| Group A | Change in Local Tissue Water (LTW) | M25 Probe: 7 cm From Bottom of Patella (along midline) | 2.3 cm | Standard Deviation 5.6 |
| Group A | Change in Local Tissue Water (LTW) | L50 Probe: 7 cm From Bottom of Patella (along midline) | 3.4 cm | Standard Deviation 6.9 |
| Group A | Change in Local Tissue Water (LTW) | M25 Probe: 7 cm From Top of Patella (along midline) | 1.3 cm | Standard Deviation 1.6 |
| Group A | Change in Local Tissue Water (LTW) | L50 Probe: 7 cm From Top of Patella (along midline) | -0.8 cm | Standard Deviation 1.6 |
| Group A | Change in Local Tissue Water (LTW) | M25 Probe: 7 cm Below Inguinal Crease (along midline) | 1.3 cm | Standard Deviation 3.7 |
| Group A | Change in Local Tissue Water (LTW) | L50 Probe: 7 cm Below Inguinal Crease (along midline) | -1.2 cm | Standard Deviation 1.5 |
| Group A | Change in Local Tissue Water (LTW) | M25 Probe: Abdominal Wall (7 cm below umbilicus) | 0.9 cm | Standard Deviation 3.6 |
| Group A | Change in Local Tissue Water (LTW) | L50 Probe: Abdominal Wall (7 cm below umbilicus) | -0.1 cm | Standard Deviation 1.4 |
| Group B | Change in Local Tissue Water (LTW) | L50 Probe: Abdominal Wall (7 cm below umbilicus) | -1.1 cm | Standard Deviation 2.7 |
| Group B | Change in Local Tissue Water (LTW) | M25 Probe: Dorsum of Central Foot | -1.1 cm | Standard Deviation 5.4 |
| Group B | Change in Local Tissue Water (LTW) | M25 Probe: 7 cm From Top of Patella (along midline) | 2.4 cm | Standard Deviation 1.4 |
| Group B | Change in Local Tissue Water (LTW) | M25 Probe: 7 cm Below Inguinal Crease (along midline) | 2.0 cm | Standard Deviation 2.1 |
| Group B | Change in Local Tissue Water (LTW) | L50 Probe: Dorsum of Central Foot | -6.3 cm | Standard Deviation 9.6 |
| Group B | Change in Local Tissue Water (LTW) | L50 Probe: 7 cm From Bottom of Patella (along midline) | -0.3 cm | Standard Deviation 3.5 |
| Group B | Change in Local Tissue Water (LTW) | M25 Probe: Abdominal Wall (7 cm below umbilicus) | 0.9 cm | Standard Deviation 1.8 |
| Group B | Change in Local Tissue Water (LTW) | M25 Probe: Posterior to Medial Malleolus | 3.2 cm | Standard Deviation 4.5 |
| Group B | Change in Local Tissue Water (LTW) | L50 Probe: 7 cm From Top of Patella (along midline) | -0.2 cm | Standard Deviation 1.8 |
| Group B | Change in Local Tissue Water (LTW) | M25 Probe: 7 cm From Bottom of Patella (along midline) | 0.6 cm | Standard Deviation 5.5 |
| Group B | Change in Local Tissue Water (LTW) | L50 Probe: Posterior to Medial Malleolus | 3.4 cm | Standard Deviation 9 |
| Group B | Change in Local Tissue Water (LTW) | L50 Probe: 7 cm Below Inguinal Crease (along midline) | 1.3 cm | Standard Deviation 0.7 |
| Group C | Change in Local Tissue Water (LTW) | L50 Probe: Posterior to Medial Malleolus | 2.5 cm | Standard Deviation 6.3 |
| Group C | Change in Local Tissue Water (LTW) | M25 Probe: 7 cm From Bottom of Patella (along midline) | 2.0 cm | Standard Deviation 5.8 |
| Group C | Change in Local Tissue Water (LTW) | L50 Probe: 7 cm Below Inguinal Crease (along midline) | 0.6 cm | Standard Deviation 1.9 |
| Group C | Change in Local Tissue Water (LTW) | L50 Probe: 7 cm From Bottom of Patella (along midline) | 0.1 cm | Standard Deviation 6.4 |
| Group C | Change in Local Tissue Water (LTW) | M25 Probe: 7 cm From Top of Patella (along midline) | 3.1 cm | Standard Deviation 4.4 |
| Group C | Change in Local Tissue Water (LTW) | L50 Probe: 7 cm From Top of Patella (along midline) | 3.2 cm | Standard Deviation 4.6 |
| Group C | Change in Local Tissue Water (LTW) | M25 Probe: Abdominal Wall (7 cm below umbilicus) | 1.3 cm | Standard Deviation 5.3 |
| Group C | Change in Local Tissue Water (LTW) | M25 Probe: Dorsum of Central Foot | 2.9 cm | Standard Deviation 10.8 |
| Group C | Change in Local Tissue Water (LTW) | L50 Probe: Dorsum of Central Foot | -0.9 cm | Standard Deviation 10.4 |
| Group C | Change in Local Tissue Water (LTW) | M25 Probe: 7 cm Below Inguinal Crease (along midline) | 0.9 cm | Standard Deviation 3 |
| Group C | Change in Local Tissue Water (LTW) | M25 Probe: Posterior to Medial Malleolus | 4.7 cm | Standard Deviation 6 |
| Group C | Change in Local Tissue Water (LTW) | L50 Probe: Abdominal Wall (7 cm below umbilicus) | 0.2 cm | Standard Deviation 1.6 |
Other Pre-specified
Change in Skin Thickness
Change in skin thickness measured by ultrasound. Ultrasound measures were collected at 5 anatomical locations. A negative value is associated with a clinically desirable reduction in skin thickness (a surrogate measure of oedema).
Time frame: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Change in Skin Thickness | Dorsum of Central Foot | -0.09 cm | Standard Deviation 0.13 |
| Group A | Change in Skin Thickness | Posterior to Medial Malleolus | 0.12 cm | Standard Deviation 0.13 |
| Group A | Change in Skin Thickness | 7 cm From Bottom of Patella (along midline) | -0.02 cm | Standard Deviation 0.08 |
| Group A | Change in Skin Thickness | 7 cm From Top of Patella (along midline) | -0.01 cm | Standard Deviation 0.02 |
| Group A | Change in Skin Thickness | 7 cm Below Inguinal Crease (along midline) | -0.01 cm | Standard Deviation 0.05 |
| Group A | Change in Skin Thickness | Abdominal Wall (7 cm below umbilicus) | -0.01 cm | Standard Deviation 0.04 |
| Group B | Change in Skin Thickness | Abdominal Wall (7 cm below umbilicus) | 0.00 cm | Standard Deviation 0.04 |
| Group B | Change in Skin Thickness | Dorsum of Central Foot | 0.02 cm | Standard Deviation 0.11 |
| Group B | Change in Skin Thickness | 7 cm From Top of Patella (along midline) | -0.01 cm | Standard Deviation 0.04 |
| Group B | Change in Skin Thickness | 7 cm Below Inguinal Crease (along midline) | -0.01 cm | Standard Deviation 0.05 |
| Group B | Change in Skin Thickness | Posterior to Medial Malleolus | -0.06 cm | Standard Deviation 0.16 |
| Group B | Change in Skin Thickness | 7 cm From Bottom of Patella (along midline) | 0.00 cm | Standard Deviation 0.07 |
| Group C | Change in Skin Thickness | Posterior to Medial Malleolus | 0.04 cm | Standard Deviation 0.12 |
| Group C | Change in Skin Thickness | 7 cm From Bottom of Patella (along midline) | -0.03 cm | Standard Deviation 0.02 |
| Group C | Change in Skin Thickness | Abdominal Wall (7 cm below umbilicus) | -0.02 cm | Standard Deviation 0.04 |
| Group C | Change in Skin Thickness | 7 cm From Top of Patella (along midline) | 0.00 cm | Standard Deviation 0.05 |
| Group C | Change in Skin Thickness | Dorsum of Central Foot | -0.02 cm | Standard Deviation 0.04 |
| Group C | Change in Skin Thickness | 7 cm Below Inguinal Crease (along midline) | 0.00 cm | Standard Deviation 0.03 |
Post Hoc
Patient Reported Outcomes - LYMQOL
Self-reported changes in symptoms in 4 domains: function, appearance, symptoms, and emotion as well as general quality of life (QOL). Measured via LYMQOL (Lymphedema Quality of Life) questionnaire. A decrease in the the domain scores and increase in general QOL indicate a good outcome. Scores range from 1 to 4.
Time frame: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Patient Reported Outcomes - LYMQOL | Emotion | -1.4 score on a scale | Standard Deviation 3.1 |
| Group A | Patient Reported Outcomes - LYMQOL | Symptoms | -3.0 score on a scale | Standard Deviation 4 |
| Group A | Patient Reported Outcomes - LYMQOL | Function | -2.2 score on a scale | Standard Deviation 2.4 |
| Group A | Patient Reported Outcomes - LYMQOL | Appearance | -4.2 score on a scale | Standard Deviation 6.1 |
| Group A | Patient Reported Outcomes - LYMQOL | Overall Quality of Life (QOL) | -0.7 score on a scale | Standard Deviation 0.5 |
| Group B | Patient Reported Outcomes - LYMQOL | Symptoms | -1.6 score on a scale | Standard Deviation 2.9 |
| Group B | Patient Reported Outcomes - LYMQOL | Function | -0.8 score on a scale | Standard Deviation 2.9 |
| Group B | Patient Reported Outcomes - LYMQOL | Appearance | -0.6 score on a scale | Standard Deviation 4 |
| Group B | Patient Reported Outcomes - LYMQOL | Emotion | -1.0 score on a scale | Standard Deviation 5.2 |
| Group B | Patient Reported Outcomes - LYMQOL | Overall Quality of Life (QOL) | -0.7 score on a scale | Standard Deviation 1.5 |
| Group C | Patient Reported Outcomes - LYMQOL | Overall Quality of Life (QOL) | 0.3 score on a scale | Standard Deviation 0.8 |
| Group C | Patient Reported Outcomes - LYMQOL | Emotion | 0.5 score on a scale | Standard Deviation 1.6 |
| Group C | Patient Reported Outcomes - LYMQOL | Function | 0.1 score on a scale | Standard Deviation 3.4 |
| Group C | Patient Reported Outcomes - LYMQOL | Symptoms | -2.2 score on a scale | Standard Deviation 4.5 |
| Group C | Patient Reported Outcomes - LYMQOL | Appearance | -0.2 score on a scale | Standard Deviation 4.4 |